Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting

NCT05093374 | Recruiting Phase 4

• 1 other identifier: 1672_2019
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to implement quantitative assessment tools for the treatment of active neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).

Conditions

Exudative Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Number of injections

  Number of injections necessary within study period

  12 months

Secondary Outcomes (8)

• Number of injections Best-corrected visual acuity (BCVA) assessed by ETDRS Score

  12 months

• Macular fluid volumes

  12 months

• Formation of geographic-like macular atrophy

  12 months

• Formation of retinal tears

  12 months

• Chorioretinal perfusion

  12 months

Study Arms (2)

Cohort 1 - Quantitative

EXPERIMENTAL

Patients will undergo monthly follow-up visits including fluid quantification and will be retreated in case of active disease, which is defined as: * reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity compared to previous visit * new sub-retinal hemorrhage * increase \>50% in IRF volume in the central 1 mm compared to month 2 * increase \> 50 % in SRF volume in the central 1 mm compared to month 2 * in case of NO intra- and/or subretinal fluid (=less than 10nl) in visits 2 or 3, retreat if fluid in central 1mm ≥ 10nl Presence/change of sub- and intraretinal fluid will be assessed objectively by AI software and the results will be provided during the visit to the investigator. The final decision for/against retreatment is always made by the discretion of the clinical investigator.

Drug: anti-VEGF agent

Cohort 2 - Qualitative

ACTIVE COMPARATOR

Patients will undergo monthly follow-up visits. Treatment will be performed in case of active disease, which is defined as: * reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity * new sub-retinal hemorrhage * any fluid In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment.

Drug: anti-VEGF agent

Interventions

anti-VEGF agent DRUG

All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented. Presence/change of sub- and intraretinal fluid will be assessed objectively by AI software and the results will be provided during the visit to the investigator. The final decision for/against retreatment is always made by the discretion of the clinical investigator. Should the Investigators decision differ from the study protocol, the reason will be indicated in the CRF.

Also known as: Cohort 1 - Quantitative

Cohort 1 - Quantitative

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 50 years
• Active neovascular AMD (classic, occult choroidal neovascularization (CNV), RAP lesion or PCV lesion) assessed by OCT, OCTA, FA
• Patients who have a BCVA score better or equal 0.1 (20/200) in the study eye using ETDRS
• No significant fibrosis or geographic atrophy (GA) involving the fovea
• Willingness and ability to comply with study visits and study procedures
• Signed informed consent form

You may not qualify if:

• Hypersensitivity to Fluoresceine, Ranibizumab, Aflibercept, Brolucizumab or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
• Any surgical treatment of the eye within 3 months prior to baseline in the study eye
• History of pseudophakic cystoid macular edema (Irvine Gass Syndrome)
• History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 0, or a history of post-operative complications within the last 12 months preceding Visit 0 in the study eye (uveitis, cyclitis etc.)
• History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio \>0,9
• Aphakia in the study eye
• Presence of a retinal pigment epithelial tear involving the macula in the study eye
• Any concurrent intraocular condition in the study eye (e.g. advanced cataract or diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the twelve-month study period to prevent or treat visual loss that might result from that condition
• Active intraocular inflammation (grade trace or above) in the study eye
• Active or suspected ocular or periocular infection in the study eye
• Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
• Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
• Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
• Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery) during the study period
• Presence of corneal decompensation, haze or scaring with an impact on BCVA

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Ophthalmology, Medical University of Vienna, Austria

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Stefan Sacu, MD

  Medical University of Vienna, Dept. of Ophthalmology and Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Sacu, MD

CONTACT

+43 1 40400; stefan.sacu@meduniwien.ac.at

Ursula Schmidt-Erfurth, MD

CONTACT

+43 1 40400; ursula.schmidt-erfurth@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Vienna Clinical Trial Center, Dept. of Ophthalmology and Optometry

Model Details: Cohort 1: Quantitative assessment: Treatment decision with support of artificial intelligence software. (n=145) Cohort 2: Qualitative assessment: Treatment decision without support of artificial intelligence software. (n=145)

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: October 26, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)